Trial Outcomes & Findings for Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis (NCT NCT00597012)

Last Updated: 2025-10-03

Results Overview

Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

351 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2025-10-03

Participant Flow

The Meniscal Tear in Osteoarthritis Research (MeTeOR) trial was performed in seven academic referral centers with enrollment occurring from June 2008 through August 2011.

Participant milestones

Participant milestones
Measure	Arthroscopic Partial Meniscectomy (APM) Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.	Physical Therapy (PT) Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Study STARTED	174	177
Overall Study COMPLETED	161	169
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Arthroscopic Partial Meniscectomy (APM) Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.	Physical Therapy (PT) Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Overall Study Death	1	1
Overall Study Underwent Total Knee Replacement (TKR)	3	1
Overall Study Withdrawal by Subject	7	4
Overall Study Ineligible	2	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.	Total n=330 Participants Total of all reporting groups
Age, Customized	59.0 years STANDARD_DEVIATION 7.9 • n=5 Participants	57.8 years STANDARD_DEVIATION 6.8 • n=7 Participants	58.4 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	97 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	72 Participants n=7 Participants	143 Participants n=5 Participants
Race/Ethnicity, Customized White	138 participants n=5 Participants	142 participants n=7 Participants	280 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Index Knee Right	70 participants n=5 Participants	68 participants n=7 Participants	138 participants n=5 Participants
Index Knee Left	91 participants n=5 Participants	101 participants n=7 Participants	192 participants n=5 Participants
Mean Body-Mass Index	30.0 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.1 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants
WOMAC physical-function score	37.1 Units on a scale STANDARD_DEVIATION 17.9 • n=5 Participants	37.5 Units on a scale STANDARD_DEVIATION 18.3 • n=7 Participants	37.3 Units on a scale STANDARD_DEVIATION 18.1 • n=5 Participants
KOOS pain score	46.0 Units on a scale STANDARD_DEVIATION 15.5 • n=5 Participants	47.2 Units on a scale STANDARD_DEVIATION 16.4 • n=7 Participants	46.6 Units on a scale STANDARD_DEVIATION 16.0 • n=5 Participants
Mental Health Index 5 score	74.8 Units on a scale STANDARD_DEVIATION 12.9 • n=5 Participants	74.0 Units on a scale STANDARD_DEVIATION 13.9 • n=7 Participants	74.4 Units on a scale STANDARD_DEVIATION 13.5 • n=5 Participants
SF-36 Physical Activity score	44.3 Units on a scale STANDARD_DEVIATION 23.7 • n=5 Participants	43.3 Units on a scale STANDARD_DEVIATION 23.3 • n=7 Participants	43.8 Units on a scale STANDARD_DEVIATION 23.5 • n=5 Participants
Kellgren-Lawrence grade 0	34 participants n=5 Participants	36 participants n=7 Participants	70 participants n=5 Participants
Kellgren-Lawrence grade 1	26 participants n=5 Participants	35 participants n=7 Participants	61 participants n=5 Participants
Kellgren-Lawrence grade 2	37 participants n=5 Participants	39 participants n=7 Participants	76 participants n=5 Participants
Kellgren-Lawrence grade 3	45 participants n=5 Participants	39 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
WOMAC Functional Status - Difference From Baseline	20.9 Score Interval 17.9 to 23.9	18.5 Score Interval 15.6 to 21.5

SECONDARY outcome

Timeframe: Baseline to 6 months

Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization.

Outcome measures

Outcome measures
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
KOOS Pain - Difference From Baseline	24.2 Score Interval 21.3 to 27.1	21.3 Score Interval 18.4 to 24.2

SECONDARY outcome

Timeframe: 6 months

Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity.

Outcome measures

Outcome measures
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
SF-36 Physical Functional Status Scale - Difference From Baseline	24.2 Score Interval 20.3 to 28.0	23.1 Score Interval 19.2 to 27.0

SECONDARY outcome

Timeframe: Baseline to 60 months

Number of subjects that elected to undergo Total Knee Replacement or Total Knee Arthroplasty between baseline and 60 month follow up. Intended to show the total number of participants that underwent Total Knee Replacement in the period following the initial intervention through 60 month follow up.

Outcome measures

Outcome measures
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Total Knee Replacement - Subjects Received	16 Participants	9 Participants

SECONDARY outcome

Timeframe: 60 months

Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the mean KOOS pain for each of the study groups 60 months after randomization.

Outcome measures

Outcome measures
Measure	Arthroscopic Partial Meniscectomy n=161 Participants Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.	Physical Therapy n=169 Participants Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
KOOS Pain - Mean at 60 Months	18.2 score on a scale Interval 15.4 to 20.9	19.4 score on a scale Interval 16.7 to 22.1

Adverse Events

Arthroscopic Partial Meniscectomy

Serious events: 3 serious events

Other events: 15 other events

Deaths: 1 deaths

Physical Therapy

Serious events: 2 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arthroscopic Partial Meniscectomy n=174 participants at risk Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.	Physical Therapy n=177 participants at risk Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Cardiac disorders Cardiovascular	1.1% 2/174 • Number of events 2 • 60 months	1.1% 2/177 • Number of events 2 • 60 months
Vascular disorders Hypoxemia	0.57% 1/174 • Number of events 1 • 60 months	0.00% 0/177 • 60 months

Other adverse events

Other adverse events
Measure	Arthroscopic Partial Meniscectomy n=174 participants at risk Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.	Physical Therapy n=177 participants at risk Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
Musculoskeletal and connective tissue disorders Muskuloskeletal	4.0% 7/174 • Number of events 7 • 60 months	3.4% 6/177 • Number of events 6 • 60 months
Musculoskeletal and connective tissue disorders Pain in the back, hip, or foot	1.1% 2/174 • Number of events 2 • 60 months	2.3% 4/177 • Number of events 4 • 60 months
Cardiac disorders Cardiovascular	3.4% 6/174 • Number of events 6 • 60 months	1.7% 3/177 • Number of events 3 • 60 months

Additional Information

Jeffrey N. Katz, MD, MSc

The Brigham and Women's Hospital

Phone: 617-732-5338

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place